MAX · Intervertebral Fusion Device With Bone Graft, Lumbar
Orthopedic · 21 CFR 888.3080 · Class 2
Overview
| Product Code | MAX |
|---|---|
| Device Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Regulation | 21 CFR 888.3080 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.
Classification Rationale
(1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
Special Controls
*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
Cleared Devices (890)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254017 | SWINGO-3D Lumbar Cage System | Implanet | Feb 26, 2026 | SESE |
| K253583 | LUX Expandable Lumbar Interbody System | Xenix Medical | Feb 23, 2026 | SESE |
| K250773 | Luna® Ti Interbody Fusion System | Spinal Elements, Inc. | Feb 4, 2026 | SESE |
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System | Life Spine, Inc. | Jan 23, 2026 | SESE |
| K253266 | Titanium Interbody System | Spine Innovation, LLC | Jan 8, 2026 | SESE |
| K253577 | IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter) | Medicrea International S.A.S. (Medtronic) | Dec 19, 2025 | SESE |
| K252610 | ZSFab Lumbar Interbody System | Zsfab, Inc. | Nov 25, 2025 | SESE |
| K252351 | UniSpace® TPLIF Cage | Cg Medtech Co., Ltd. | Oct 28, 2025 | SESE |
| K253377 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. | Oct 24, 2025 | SESE |
| K251479 | Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF)) | Mobarn Medical Devices, LLC | Sep 18, 2025 | SESE |
| K251444 | Endoskeleton Interbody Systems | Medtronic Sofamor Danek USA, Inc. | Sep 4, 2025 | SESE |
| K251969 | Atlas Spine Project X Expandable Posterior Lumbar Interbody System | Atlas Spine, Inc. | Aug 15, 2025 | SESE |
| K252113 | PRADO Lumbar Interbody Fusion System | Bethesda Medical Devices | Aug 5, 2025 | SESE |
| K251016 | MectaLIF 3D Metal | Medacta International S.A. | Jul 17, 2025 | SESE |
| K251741 | PathLoc Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | Jul 8, 2025 | SESE |
| K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System | Life Spine, Inc. | Jul 7, 2025 | SESE |
| K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams | Carlsmed, Inc. | Jul 7, 2025 | SESE |
| K250987 | aprevo® posterior/transforaminal lumbar interbody fusion device | Carlsmed, Inc. | Jun 30, 2025 | SESE |
| K243816 | Testa TP Pivoting Spacer System | Spine Wave, Inc. | Jun 27, 2025 | SESE |
| K251003 | X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. | Jun 25, 2025 | SESE |
| K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. | Jun 16, 2025 | SESE |
| K243973 | FIX-L PEEK PLIF and T-PLIF System | Jeil Medical Corporation | Jun 12, 2025 | SESE |
| K251335 | Tera Lumbar Interbody Fusion System (Various PNs) | Acuity Surgical Devices, LLC | Jun 2, 2025 | SESE |
| K243116 | FlareHawk Interbody Fusion System | Integrity Implants Inc. Dba Accelus | May 21, 2025 | SESE |
| K250669 | Adaptix Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | Apr 22, 2025 | SESE |
| K250373 | ProLift Expandable Spacer System | Life Spine, Inc. | Apr 9, 2025 | SESE |
| K250667 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | Apr 4, 2025 | SESE |
| K243074 | Spectrum Spine Lumbar Cage System | Spectrum Spine, Inc. | Apr 4, 2025 | SESE |
| K250186 | GoLIF! Lumbar Interbody Fusion System | Getset Surgical, SA | Mar 21, 2025 | SESE |
| K242771 | Tesera-k PL System and Tesera-k XL System | Kyocera Medical Technologies, Inc. | Mar 20, 2025 | SESE |
| K241783 | FortiVy OsteoVy Lumbar IBF | Vy Spine, LLC | Mar 18, 2025 | SESE |
| K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer | Alphatec Spine | Feb 3, 2025 | SESE |
| K243739 | AxCess® Expandable Interbody System | Elliquence, LLC | Jan 24, 2025 | SESE |
| K243668 | ProLift Pivot Expandable Spacer System | Life Spine, Inc. | Jan 23, 2025 | SESE |
| K243670 | Idys® LIF | Clariance | Dec 31, 2024 | SESE |
| K241073 | DZ-Tabone Intervertebral Body Fusion Device | Shenzhen Dazhou Medical Technology Co., Ltd. | Dec 6, 2024 | SESE |
| K242829 | BluEX Lumbar Expandable Cage System | L&K BIOMED Co., Ltd. | Oct 23, 2024 | SESE |
| K242589 | Scarlet® AL-T | Spineart SA | Oct 23, 2024 | SESE |
| K233947 | KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage System | Ctl Medical Corporation | Oct 10, 2024 | SESE |
| K242826 | ProLift Wedge Expandable Spacer System | Life Spine, Inc. | Oct 8, 2024 | SESE |
| K242267 | Gemini Medical Cage System | ZheJiang Decans Medical Devices Co., Ltd. | Oct 8, 2024 | SESE |
| K242457 | EARP Interbody System | Retropsoas Technologies, LLC | Oct 7, 2024 | SESE |
| K242364 | IdentiTi II Interbody System | Alphatec Spine, Inc. | Oct 4, 2024 | SESE |
| K240889 | ARTFX Lumbar PEEK Cages | Artfx Medical | Oct 2, 2024 | SESE |
| K233807 | LumiVy Lumbar IBF System | Vy Spine, LLC | Sep 24, 2024 | SESE |
| K242147 | Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System | Alphatec Spine, Inc. | Sep 20, 2024 | SESE |
| K241332 | aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device | Carlsmed, Inc. | Sep 20, 2024 | SESE |
| K242509 | HAnano InterFuse(R) Modular Interbody | Next Orthosurgical | Sep 19, 2024 | SESE |
| K240250 | 3D Printed PEEK Interbody System | Nvision Biomedical Technologies, Inc. | Sep 17, 2024 | SESE |
| K241438 | Signus Tetris St; Signus Tetris R St | Signus Medizintechnik GmbH | Sep 11, 2024 | SESE |
| K241164 | IB3D PL Spinal System | Medicrea International S.A.S. (Medtronic) | Sep 6, 2024 | SESE |
| K234035 | COSINE Spacer | Globus Medical, Inc. | Sep 6, 2024 | SESE |
| K232996 | Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) | Shanghai Iatrical-Ti Technologies CO , Ltd. | Sep 6, 2024 | SESE |
| K241605 | Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology | Nanovis, LLC | Sep 5, 2024 | SESE |
| K241328 | aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X) | Carlsmed, Inc. | Aug 12, 2024 | SESE |
| K240326 | Solar Lumbar Interbody Fusion System | Degen Medical, Inc. | Jul 29, 2024 | SESE |
| K241413 | sagAlign Lumbar Cage System (Various PNs) | Acuity Surgical Devices, LLC | Jul 17, 2024 | SESE |
| K234077 | SPIRA® Anterior Lumbar Spacers | Camber Spine Technologies | Jul 12, 2024 | SESE |
| K241019 | aprevo® TLIF-C Articulating System | Carlsmed | Jul 9, 2024 | SESE |
| K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System | SeaSpine Orthopedics Corporation | Jun 20, 2024 | SESE |
| K240830 | Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System | Orthofix Medical, Inc. | Jun 20, 2024 | SESE |
| K240749 | PILLAR SA Ti Spacer System (82-XXX) | Orthofix, Inc. | May 28, 2024 | SESE |
| K240566 | Reef L Interbody System; WaveForm L Interbody System | SeaSpine Orthopedics Corporation | Apr 26, 2024 | SESE |
| K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System | Zavation Medical Products, LLC | Apr 10, 2024 | SESE |
| K232792 | icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage) | Icotec AG | Apr 5, 2024 | SESE |
| K234150 | Lucent® XP | Spinal Elements | Mar 27, 2024 | SESE |
| K232282 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device | Carlsmed, Inc. | Mar 22, 2024 | SESE |
| K233375 | Tranquil-L Interbody System | Nexus Spine, LLC | Mar 20, 2024 | SESE |
| K233075 | BioGend Interbody Fusion System 001 Cage | Biogend Therapeutics Co., Ltd. | Mar 6, 2024 | SESE |
| K234087 | restor3d TIDAL Lumbar Interbody Fusion System | Restor3D | Jan 22, 2024 | SESE |
| K233744 | Curiteva Porous PEEK Lumbar Interbody Fusion System | Curiteva, Inc. | Jan 18, 2024 | SESE |
| K233694 | Meridian Interbody System; WaveForm A Interbody System | SeaSpine Orthopedics Corporation | Jan 12, 2024 | SESE |
| K230872 | Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction Changeable Lumbar Cage System, KEYSTONE Cage System | Shanghai Sanyou Medical Co, Ltd. | Dec 12, 2023 | SESE |
| K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System | Corelink, LLC | Dec 8, 2023 | SESE |
| K232611 | TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System | Life Spine, Inc. | Nov 30, 2023 | SESE |
| K232069 | Expandable Lumbar Fusion Cage (Type I,Type II) | Shanghai Reach Medical Instrument Co, Ltd. | Nov 29, 2023 | SESE |
| K232292 | Peridot-EX Expandable Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | Nov 7, 2023 | SESE |
| K232504 | Calibrate CCX Interbody System | Alphatec Spine, Inc. | Oct 13, 2023 | SESE |
| K232014 | CONDUIT ATP Inserters | Enztec Limited | Sep 1, 2023 | SESE |
| K231680 | AccelFix Lumbar Expandable Cage System | L&K BIOMED Co., Ltd. | Aug 24, 2023 | SESE |
| K221894 | Lumbar Expandable lnterbody Spacers -Additional Indications/Implants | Globus Medical, Inc. | Aug 3, 2023 | SESE |
| K231275 | Exceed Biplanar Expandable Interbody System | Spine Wave, Inc. | Jul 25, 2023 | SESE |
| K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | Alphatec Spine, Inc. | Jul 13, 2023 | SESE |
| K231241 | NanoHive Medical Lumbar Interbody System | NanoHive Medical, LLC | Jul 12, 2023 | SESE |
| K230942 | SPIRA® Posterior Lumbar Spacers | Camber Spine Technologies | Jul 11, 2023 | SESE |
| K231252 | Ventana L Spinal System | Spinal Elements, Inc. | Jun 30, 2023 | SESE |
| K231199 | Solar Lumbar Interbody Fusion System | Degen Medical | Jun 16, 2023 | SESE |
| K231359 | RODIN Expandable Lumbar Cage System | Ctl Medical Corporation | Jun 9, 2023 | SESE |
| K230851 | Kodiak Lumbar Spacer System | Met One Technologies, LLC | May 26, 2023 | SESE |
| K231140 | aprevo® transforaminal lumbar interbody fusion device | Carlsmed, Inc. | May 19, 2023 | SESE |
| K230219 | Eminent Spine 3D Lumbar Interbody Fusion Systems | Eminent Spine, LLC | May 16, 2023 | SESE |
| K223335 | SIRION Lateral Lumbar Interbody System | Astura Medical | May 9, 2023 | SESE |
| K223430 | ProLift Micro Expandable Spacer System | Life Spine, Inc. | May 4, 2023 | SESE |
| K223868 | PYXIS 3D Titanium Cage System | GS Medical Co., Ltd. | Apr 26, 2023 | SESE |
| K223611 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | Mar 29, 2023 | SESE |
| K223418 | DeGen Impulse AM System | Degen Medical | Mar 17, 2023 | SESE |
| K223688 | CONDUIT Lateral Lumbar Intervertebral Fusion Cage, CONDUIT Instruments | Medos International Sàrl | Mar 8, 2023 | SESE |
| K223776 | PEEK Spinal Infusion Cage | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | Mar 3, 2023 | SESE |
| K223174 | X-Pac Expandable LLIF Cage System | Expanding Innovations, Inc. | Feb 14, 2023 | SESE |
| K223474 | PathLoc-TA Expandable Lumbar Cage System | L&K BIOMED Co., Ltd. | Jan 13, 2023 | SESE |
| K223412 | LumiVy Lumbar IBF System | Vy Spine, LLC | Jan 6, 2023 | SESE |
| K223671 | CONDUIT LLIF Straight Inserters | Enztec Limited | Jan 5, 2023 | SESE |
| K223654 | Medussa-PL Cage | Medyssey USA, Inc. | Dec 28, 2022 | SESE |
| K213653 | 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM | Solco Biomedical Company India Private Limited | Dec 19, 2022 | SESE |
| K223251 | Hexanium PLIF | Spinevision, S.A.S. | Dec 16, 2022 | SESE |
| K223153 | Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | Dec 16, 2022 | SESE |
| K221182 | Southern Transforaminal Lumbar Interbody Fusion (TLIF) | Southern Medical (Pty) , Ltd. | Dec 8, 2022 | SESE |
| K221806 | TruLift Lateral Expandable Spacer System & Lateral Plate System | Life Spine, Inc. | Dec 5, 2022 | SESE |
| K222455 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | Nov 18, 2022 | SESE |
| K222732 | WaveForm A Interbody System | SeaSpine Orthopedics Corporation | Nov 7, 2022 | SESE |
| K221719 | ABTross ALIF Expandable Cage System | Aegis Spine, Inc. | Nov 3, 2022 | SESE |
| K223065 | Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices | Adcura, Inc. | Oct 26, 2022 | SESE |
| K222203 | DualXSLIM(R) T/PLIF | Amplify Surgical, Inc. | Oct 18, 2022 | SESE |
| K222797 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | Oct 14, 2022 | SESE |
| K221858 | ZSFab Lumbar Interbody System | Zsfab, Inc. | Oct 14, 2022 | SESE |
| K221172 | FOCUS Interbody System | Oc Medical Devices | Oct 14, 2022 | SESE |
| K222028 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System | Alphatec Spine | Oct 7, 2022 | SESE |
| K213417 | Ghost Spacer System | Life Spine, Inc. | Sep 29, 2022 | SESE |
| K213641 | MONDRIAN ALIF Cage with Supplementary Fixation Plate | Ctl Medical Corporation | Sep 15, 2022 | SESE |
| K220953 | ChoiceSpine TigerShark M, Modular Interbody System | Choice Spine, LLC | Sep 13, 2022 | SESE |
| K221325 | CONDUIT Lateral Switch Plate | Medos International SARL | Aug 25, 2022 | SESE |
| K221844 | TDM Lumbar Interbody Fusion Cage System | Tdm Co., Ltd. | Aug 17, 2022 | SESE |
| K222082 | aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices | Carlsmed, Inc. | Aug 12, 2022 | SESE |
| K221687 | Pegasus-X Expandable PLIF System | GS Medical Co., Ltd. | Jul 27, 2022 | SESE |
| K221535 | Align Lumbar Interbody Fusion System | Acuity Surgical Devices, LLC | Jul 22, 2022 | SESE |
| K220449 | DePuy CONDUIT LLIF SQUID Inserter | Enztec Limited | Jun 28, 2022 | SESE |
| K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System | Nu Vasive, Incorporated | Jun 21, 2022 | SESE |
| K220523 | restor3d TiDAL Lumbar Interbody Fusion Device | Restor3D | Jun 17, 2022 | SESE |
| K220782 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody System | Alphatec Spine, Inc. | Jun 9, 2022 | SESE |
| K220581 | Zavation eZspand Interbody System | Zavation Medical Products, LLC | Jun 2, 2022 | SESE |
| K220902 | Navagio Lumbar Cage | Kalitec Medical, LLC | May 27, 2022 | SESE |
| K220711 | SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System | SeaSpine Orthopedics Corporation | May 10, 2022 | SESE |
| K213420 | WaveForm L System, WaveForm TO System, WaveForm TA System | SeaSpine Orthopedics Corporation | May 4, 2022 | SESE |
| K212477 | EARP Interbody System | Nvision Biomedical Technologies, Inc. | Apr 28, 2022 | SESE |
| K214010 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA | Apr 12, 2022 | SESE |
| K212811 | Ti3Z Lumbar Interbody System | Zavation Medical Products, LLC | Apr 12, 2022 | SESE |
| K213355 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | Mar 25, 2022 | SESE |
| K220655 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | Mar 24, 2022 | SESE |
| K220453 | FlareHawk Interbody Fusion System | Integrity Implants, Inc. | Mar 24, 2022 | SESE |
| K220096 | Genesys Spine 3DP Lumbar Interbody System | Genesys Spine | Mar 9, 2022 | SESE |
| K213441 | PathLoc Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | Mar 9, 2022 | SESE |
| K212930 | LumiVy Lumbar IBF System | Vy Spine, LLC | Feb 16, 2022 | SESE |
| K213951 | FORZA XP Expandable Spacer System | Orthofix US, LLC | Jan 5, 2022 | SESE |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty | Nu Vasive, Incorporated | Dec 23, 2021 | SESE |
| K212524 | Anteralign Spinal System with Titan nanoLOCK Surface Technology | Medtronic Sofamor Danek USA, Inc. | Dec 8, 2021 | SESE |
| K212075 | ShurFit Lumbar Interbody System | Precision Spine, Inc. | Dec 8, 2021 | SESE |
| K212050 | NGM WAVE PLIF Cage | NGMedical GmbH | Dec 1, 2021 | SESE |
| K212653 | Catalyft LS Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | Nov 19, 2021 | SESE |
| K211845 | Deploy Expandable Interbody System | Southern Spine, LLC | Nov 16, 2021 | SESE |
| K212823 | DePuy CONDUIT LLIF Angled Inserters | Enztec Limited | Nov 1, 2021 | SESE |
| K212831 | MectaLIF Extension | Medacta International S.A. | Oct 29, 2021 | SESE |
| K212389 | Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF | Intelivation, LLC | Oct 29, 2021 | SESE |
| K212520 | ProLift Micro Expandable Spacer System | Life Spine, Inc. | Oct 8, 2021 | SESE |
| K211740 | DualX | Amplify Surgical, Inc. | Sep 29, 2021 | SESE |
| K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System | Alphatec Spine, Inc. | Sep 22, 2021 | SESE |
| K211689 | KEYSTONE PEEK Cage System | Shanghai Sanyou Medical Co, Ltd. | Sep 21, 2021 | SESE |
| K211474 | Kleiner KG2 System | BAAT Medical Products B.V. | Sep 14, 2021 | SESE |
| K212540 | Explorer TO System | SeaSpine Orthopedics Corporation | Sep 10, 2021 | SESE |
| K203014 | EndoLIF Delta-Cage and DoubleWedge-Cage | Joimax GmbH | Sep 1, 2021 | SESE |
| K212070 | KMTI S141 Lumbar Interbody Fusion System | Kyocera Medical Technologies, Inc. | Aug 30, 2021 | SESE |
| K210090 | Impulse AM Interbody Fusion System | Degen Medical | Aug 30, 2021 | SESE |
| K211413 | BEE PLIF Cage | NGMedical GmbH | Aug 27, 2021 | SESE |
| K210800 | IO Expandable Lumbar Interbody Fusion System | MiRus, LLC | Aug 20, 2021 | SESE |
| K211873 | PSX Interbody System | Alphatec Spine, Inc. | Aug 10, 2021 | SESE |
| K211388 | Lateral Spine Truss System (LSTS) Interbody Fusion Device | 4Web Medical, Inc. | Aug 5, 2021 | SESE |
| K210497 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aPOD-L NanoMetalene, SeaSpine Vu ePOD System, SeaSpine Vu aPOD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System | SeaSpine Orthopedics Corporation | Jul 7, 2021 | SESE |
| K203003 | Pantheon IBFD | Pantheon Spinal | Jul 7, 2021 | SESE |
| K210542 | aprevo Transforaminal IBF | Carlsmed, Inc. | Jun 30, 2021 | SESE |
| K210044 | Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System | Spinal Elements, Inc. | Jun 30, 2021 | SESE |
| K211306 | LABYRINTH | Zavation Medical Products, LLC | Jun 24, 2021 | SESE |
| K210595 | SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers | Camber Spine Technologies, LLC | Jun 15, 2021 | SESE |
| K203802 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | Jun 7, 2021 | SESE |
| K210583 | SeaSpine WaveForm A Interbody System | SeaSpine Orthopedics Corporation | Jun 2, 2021 | SESE |
| K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System | Medtronic Sofamor Danek USA, Inc. | May 26, 2021 | SESE |
| K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | May 24, 2021 | SESE |
| K210214 | NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System | Nu Vasive, Incorporated | May 24, 2021 | SESE |
| K210439 | NuVasive MOD-EX XLIF Interbody System | Nu Vasive, Incorporated | May 12, 2021 | SESE |
| K210728 | CONDUIT Instruments | Medos International SARL | May 6, 2021 | SESE |
| K210061 | ProLift Lateral HELO Fixated | Life Spine, Inc. | Apr 30, 2021 | SESE |
| K201024 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, LLC | Apr 29, 2021 | SESE |
| K200919 | Idys ALIF 3DTi | Clariance | Apr 12, 2021 | SESE |
| K203254 | Lucent 3D Spinal System | Spinal Elements, Inc. | Mar 26, 2021 | SESE |
| K203038 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | Mar 26, 2021 | SESE |
| K203361 | ProLift Wedge Expandable Spacer System | Life Spine, Inc. | Mar 17, 2021 | SESE |
| K210359 | Hexanium TLIF | Spinevision, S.A.S. | Mar 10, 2021 | SESE |
| K203576 | FORZA Ti Spacer System | Orthofix, Inc. | Mar 3, 2021 | SESE |
| K210155 | Duo Expandable Interbody Fusion System | Spineology, Inc. | Feb 19, 2021 | SESE |
| K202380 | Born PT-LIF Cage HA | Spineworxx AG | Feb 19, 2021 | SESE |
| K200551 | MectaLIF Transforaminal TiPEEK | Medacta Inernational SA | Feb 12, 2021 | SESE |
| K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers | Globus Medical, Inc. | Feb 2, 2021 | SESE |
| K203531 | XYPAN Expandable Lumbar Cage System | Aegis Spine, Inc. | Jan 29, 2021 | SESE |
| K203327 | VERTACONNECT TLIF Cage | Signus Medizintechnik | Jan 25, 2021 | SESE |
| K203683 | CarboClear Lumbar Cage System | Carbofix Orthpedics , Ltd. | Jan 15, 2021 | SESE |
| K203308 | Ali Interbody Fusion System | Raed M. Ali, M.D., Inc. | Jan 15, 2021 | SESE |
| K203201 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System | Nu Vasive, Incorporated | Jan 12, 2021 | SESE |
| K202495 | SIRION Lateral Lumbar Interbody Fusion | Astura Medical, LLC | Jan 6, 2021 | SESE |
| K202820 | Australis Anterior Lumbar Cage System | Prism Surgical Designs Pty, Ltd. | Dec 22, 2020 | SESE |
| K202298 | Lucent XP, Lucent XP Curved | Spinal Elements, Inc. | Dec 22, 2020 | SESE |
| K201287 | Impulse Interbody Fusion System | Degen Medical | Dec 22, 2020 | SESE |
| K201755 | WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System | SeaSpine Orthopedics Corporation | Dec 15, 2020 | SESE |
Top Applicants
- Nu Vasive, Incorporated — 34 clearances
- Medtronic Sofamor Danek USA, Inc. — 32 clearances
- Life Spine, Inc. — 25 clearances
- Spineology, Inc. — 22 clearances
- Globus Medical, Inc. — 20 clearances
